WO2003044514A1 - Procede d'evaluation de defaillance aux fins d'une analyse et analyseur associe - Google Patents

Procede d'evaluation de defaillance aux fins d'une analyse et analyseur associe Download PDF

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Publication number
WO2003044514A1
WO2003044514A1 PCT/JP2002/012035 JP0212035W WO03044514A1 WO 2003044514 A1 WO2003044514 A1 WO 2003044514A1 JP 0212035 W JP0212035 W JP 0212035W WO 03044514 A1 WO03044514 A1 WO 03044514A1
Authority
WO
WIPO (PCT)
Prior art keywords
acceleration
current
sample
change
measuring means
Prior art date
Application number
PCT/JP2002/012035
Other languages
English (en)
Japanese (ja)
Inventor
Yoshimitsu Morita
Teppei Shinno
Original Assignee
Arkray, Inc.
Matsushita Electric Industrial Co., Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Arkray, Inc., Matsushita Electric Industrial Co., Ltd. filed Critical Arkray, Inc.
Priority to JP2003546096A priority Critical patent/JP4260017B2/ja
Priority to EP02781813.7A priority patent/EP1452854B1/fr
Priority to US10/496,209 priority patent/US7083712B2/en
Priority to AU2002349662A priority patent/AU2002349662A1/en
Publication of WO2003044514A1 publication Critical patent/WO2003044514A1/fr

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28—Electrolytic cell components
    • G01N27/30—Electrodes, e.g. test electrodes; Half-cells
    • G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
    • G01N27/3271—Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
    • G01N27/3274—Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration

Definitions

  • the present invention provides a method for determining whether or not the conditions of the analysis processing are appropriate when performing analysis processing of a desired sample such as measurement of the concentration of glucose / cholesterol in sampled blood.
  • a desired sample such as measurement of the concentration of glucose / cholesterol in sampled blood.
  • This method is implemented by applying a constant voltage to a pair of electrodes of a biosensor and measuring a current between the pair of electrodes.
  • the change of the current at that time is shown in FIG. 8 of the present application.
  • the current between the pair of electrodes increases thereafter.
  • the current value exceeds the first threshold value at time ta, it is determined that the sample has been introduced at that time.
  • the rate at which the current increases immediately after sample introduction depends on the amount of sample introduced into the reagent layer.When the amount of introduction is small, the current increases more slowly than when the amount is large. .
  • a current at a time tb at which a predetermined time T has elapsed from the time ta is measured.
  • the measured current value exceeds a second predetermined threshold value, it is determined that the amount of the sample introduced is sufficient.
  • the current value is equal to or less than the second threshold value, it is determined that the sample introduction amount is insufficient.
  • a fail determination is made based on a difference between two current values at a predetermined time. This can be said that the determination is made based on the slope of the curve representing the change in the current at a predetermined time, that is, the speed of the change in the current.
  • the rate of change of the current between the pair of electrodes is different between the case where the amount of the sample introduced into the reagent layer is large and the case where the amount of the sample is small. since this c not enough can be said to vary with a sufficiently large width relative small change in the amount of introduced sample to the layer, the above conventional art, precisely whether the introduced amount of the sample is sufficient Sometimes it was difficult to judge.
  • the second threshold is set to a relatively large value. It is necessary to set a higher value with a margin.
  • the method for judging a failure in the analysis process provided by the first aspect of the present invention is a method for measuring a physical amount of a sample to measure a predetermined amount of a sample required for performing the predetermined analysis process on the sample.
  • the “electric physical quantity” in the present invention corresponds to a change amount of a current, a voltage, or a charge.
  • “Acceleration of change in electrical physical quantity” means the amount of change per minute unit when the speed of change in electrical physical quantity changes over time.
  • the “speed of change of an electric physical quantity” is the amount of change per minute unit time when the value of an electric physical quantity changes with time.
  • the fail judging method of the present invention may be configured to judge whether or not the sample has a predetermined required amount based on the acceleration.
  • the failure judgment is made based on the acceleration of the change of the electric physical quantity, but this acceleration corresponds to a value obtained by differentiating the speed of the change of the electric physical quantity. For this reason, when a change occurs in the analysis processing conditions, a large change occurs in the acceleration of the electrical physical quantity, even if the change rate of the electrical physical quantity does not show a large change itself.
  • the acceleration of this change in electrical physical quantity is determined by the sample analysis process. It can be used as a parameter that changes over a large range for small changes in conditions. Therefore, if the acceleration of the change of the electrical physical quantity is used as a parameter for determining a file, it is possible to more clearly determine whether or not a certain condition for performing a sample analysis process is satisfied. It works.
  • the method for judging a failure in the analysis processing includes the steps of: A file determination method for determining whether or not certain conditions required for performing the analysis process are satisfied when performing the analysis process for determining the concentration of the component. After the sample has been introduced, the acceleration of the change in the current when the current reaches a predetermined value is determined, and based on the acceleration, certain conditions required for the analysis processing are determined. It is characterized in that it is determined whether or not the condition is satisfied. In the present invention, a configuration may be adopted in which the acceleration is compared with a predetermined threshold value, and when the acceleration is smaller than the threshold value, it is determined that the certain condition is not satisfied.
  • An analyzer provided by the third aspect of the present invention is an analyzer provided with measuring means for measuring an electrical physical quantity of a sample, wherein the analyzer comprises an electrical physical quantity measured by the measuring means. It is characterized by having an acceleration measuring means that can determine the acceleration of change.
  • the analyzer according to the present invention is characterized in that, based on the acceleration of the change of the electrical physical quantity obtained by the acceleration measuring means, a certain condition required for performing a predetermined analysis process is satisfied. It has a judgment means to judge whether or not it is satisfied.
  • the determination by the determination means is configured to be performed by comparing the acceleration with a predetermined threshold.
  • the analyzer comprises a receiving device for receiving a sample.
  • the device further comprises a mounting portion for a receiving member to which the member can be attached and detached, and the measuring means is capable of measuring an electrical physical quantity of the sample received by the receiving member mounted on the mounting portion. Have been.
  • the measuring means is a current measuring circuit.
  • an arithmetic processing means for analyzing the sample based on the current measured by the current measuring circuit of the brackets.
  • the acceleration measuring means is configured to determine an acceleration of a change in the current measured by the current measuring circuit.
  • the acceleration measuring means obtains the speed of change of the current at two times, and then calculates the current at an intermediate time between the two times based on a difference between the speeds of change of the current at these two times. It is configured to determine the acceleration of the change.
  • the arithmetic processing means determines that the certain condition is not satisfied by comparing the acceleration of the change in current obtained by the acceleration measuring means with a predetermined threshold value. It is configured.
  • the analyzer provided by the fourth aspect of the present invention includes a reagent layer that exhibits a predetermined reaction with the sample when the sample is introduced, and a pair of electrodes for applying a voltage to the reagent layer.
  • a mounting portion to which the sensor is mounted in a detachable manner current measuring means capable of measuring a current between the pair of electrodes when a constant voltage is applied to the pair of electrodes, and measurement by the current measuring means
  • an arithmetic processing means for analyzing the sample based on the measured current, wherein the current reaches a predetermined value after the sample is introduced into the reagent layer.
  • Acceleration measuring means capable of determining the acceleration of the change in the current at the time when the acceleration is calculated, and the arithmetic processing means calculates the acceleration determined by the acceleration measuring means as desired. It is characterized in that it is configured to determine whether or not a certain condition required for the analysis processing of the sample is satisfied by comparing with a certain threshold value. According to the analyzer having such a configuration, the fail judging method provided by the first aspect or the second aspect of the present invention is appropriately performed. The same effects as described above are expected. it can.
  • FIG. 1 is a circuit block diagram showing an example of the analyzer according to the present invention.
  • FIG. 2 is a perspective view illustrating an example of a biosensor.
  • FIG. 3 is an exploded perspective view of the biosensor shown in FIG.
  • FIG. 4 is a flowchart illustrating a control operation of the arithmetic processing unit of the analyzer illustrated in FIG.
  • FIG. 5A is a time chart of the voltage applied to the electrode of the biosensor
  • FIG. 5B is a time chart of the current flowing through the electrode of the biosensor.
  • FIG. 6 is an explanatory diagram showing a change in current.
  • FIG. 7 is an explanatory diagram showing acceleration of a change in current.
  • FIG. 8 is an explanatory diagram showing a conventional technique. BEST MODE FOR CARRYING OUT THE INVENTION
  • FIG. 1 shows an example of the analyzer according to the present invention.
  • the biosensor 2 shown in FIGS. 2 and 3 is used.
  • the biosensor 2 is for receiving a sample, and corresponds to an example of a receiving member according to the present invention.
  • the biosensor 2 has a structure in which a pair of electrodes 22 a and 22 b and a reagent layer 23 are provided on the upper surface of a substrate 24.
  • Have The reagent layer 23 is provided so as to collectively or individually cover the upper surfaces of the pair of electrodes 22a and 22b.
  • the periphery of the reagent layer 23 and the pair of electrodes 22 a and 22 b is covered with an insulating film 29, and one side of the insulating film 29 is provided with a pair of electrodes 22 a and 22.
  • a pair of terminal portions 27a and 27b that conduct to b are provided.
  • the spacer 25 is provided with a narrow slit 21.
  • the cover plate 26 is provided with a hole portion 28 that allows a part of the slit 21 to communicate with the outside so that the above-mentioned capillary phenomenon occurs appropriately.
  • the analyzer A of the present embodiment includes a biosensor mounting section 1, an arithmetic processing section 3, a biosensor detection circuit 40, a voltage supply circuit 41, a current measurement circuit 42, A temperature sensor 43, an acceleration measuring circuit 44, and a display device 45 are provided.
  • the biosensor mounting portion 1 is a portion corresponding to an example of a mounting portion for a receiving member according to the present invention, and has a structure in which the biosensor 2 is detachable.
  • the pair of terminal portions 27a and 27b of the biosensor 2 are electrically connected to the voltage supply circuit 41.
  • the arithmetic processing unit 3 includes, for example, a CPU and an appropriate memory connected to the CPU, and executes operation control and data processing of each unit as described later.
  • the voltage supply circuit 41 applies a predetermined voltage to the pair of electrodes 22 a and 22 b of the biosensor 2 under the control of the arithmetic processing unit 3.
  • the current measurement circuit 42 measures the current between the pair of electrodes 22a and 22b, and calculates the measured data. Output to part 3 and acceleration measurement circuit 4 4.
  • the acceleration measurement circuit 44 is a circuit that calculates the acceleration of a change in the current flowing between the pair of electrodes 22a and 22b based on the value of the current measured by the current measurement circuit 42. The specific method for this will be described later.
  • the acceleration measuring circuit 44 can be configured to be integrated with the arithmetic processing unit 3.
  • the biosensor detection circuit 40 detects when the biosensor 2 is properly mounted on the biosensor mounting section 1, and outputs a signal to that effect to the arithmetic processing section 3.
  • the temperature sensor 43 measures the temperature around the biosensor 2 and outputs the data to the arithmetic processing unit 3.
  • the display device 45 is capable of displaying a desired image under the control of the arithmetic processing unit 3, and is composed of, for example, a liquid crystal display or a CRT.
  • the arithmetic processing section 3 detects the temperature detected by the temperature sensor 43.
  • the data is stored (S2). This temperature data is used for temperature correction in glucose concentration measurement.
  • the arithmetic processing unit 3 drives the voltage supply circuit 41 to apply a constant voltage of, for example, about 500 mV to the pair of electrodes 22 a and 22 b of the biosensor 2. (S3).
  • the voltage application to the electrodes 22a and 22b is performed twice, as shown in FIG. As described later, the failure is determined by applying the voltage for the first time ⁇ 1, and the measurement result of the glucose concentration is obtained by applying the voltage for the second time ⁇ 2.
  • FIG. 6 shows the above-mentioned current change in an enlarged manner.
  • the arithmetic processing unit 3 determines that blood has been introduced at this time (S 4: YES), and The time t3 at this time is set as a reference time for performing the fail judgment.
  • the current measurement by the current measurement circuit 42 is continuously performed, and the acceleration measurement circuit 44 obtains the current value I 3 at the time t 3 (this current value I 3 is the first threshold value T 3 hl) and the current values I and I 5 at two times t1 and t5, which are before and after time t3 by a very short time (for example, about 0 to 2 seconds).
  • the acceleration of the change in the current at the reference time t3 is obtained as follows (S5).
  • the difference I b between times t 3 and t 5 is divided by the time between times t 3 and t 5
  • a value corresponding to the current change speed V 4 at the intermediate time t 4 is obtained.
  • the speeds V 2 , V 4 of the current change at times t 2, t 4 When dividing what was the difference in their time interval, the acceleration a 3 change in current at the reference time t 3 is determined.
  • the processing unit 3 compares the second threshold value which has been determined to the acceleration a 3 beforehand. The result of this comparison, if the acceleration a 3 is equal to or less than the second threshold (S 6: NO), the arithmetic processing unit 3 determines that the amount of introduced blood to reagent layer 2 3 is insufficient, After that fact is displayed on the display device 45 (S9), the subsequent processing is interrupted.
  • the amount of blood introduced is insufficient, not only the speed of current change is relatively low, but also the acceleration of current change is relatively small compared to when the amount of blood introduced is sufficient. This has been confirmed by the inventors' tests. For this reason, when the acceleration of the current change at a predetermined time is less than a certain value, it is possible to accurately judge this as an insufficient blood introduction amount.
  • the acceleration of the current change will be, for example, a curve as shown by the symbol L1 in Fig. 7. Becomes On the other hand, when the amount of introduced blood is insufficient, a broken curve indicated by a reference numeral L2 in FIG. As shown in the figure, when the amount of introduction is insufficient, the acceleration of the current change tends to be smaller over a relatively long time after time t0 than when the amount of introduction is sufficient. In particular, at the time when the acceleration of the change of the current is maximized when the amount of introduction is sufficient, and before and after that, the difference between the two accelerations becomes more remarkable.
  • a value Th2 at time t3 at which the acceleration of the curve indicated by the symbol L1 is maximized is adopted. Therefore, acceleration a 3 of the change current at the time t 3 when determined at the acceleration measurement circuit 4 4, is smaller than the second threshold value T h2, be determined that the amount of introduced blood Ru insufficient der You can.
  • the acceleration a 3 of the current change at time t 3 is a value in a time band that fluctuates greatly with a slight change in the amount of introduced blood, and when the amount of introduced blood is insufficient, the acceleration a 3 But It is significantly below the second threshold value Th2. Therefore, if there is a shortage in the amount introduced, it can be accurately determined. This means that it is not necessary to use a relatively large value as the second threshold value Th2, and the amount of blood introduced is insufficient despite the fact that the amount of blood introduced is actually sufficient. Is less likely to be determined erroneously.
  • Various methods have been known for measuring glucose concentration, and any of these methods can be used. One of those methods will be described. First, as shown in FIG. 5A, when a certain time (for example, one second) elapses from time t3 at time t6, a pair of electrodes 2 2a and 2 The application of the voltage to 2b is interrupted, and the reaction between the glucose in the blood and the reagent layer 23 is promoted.
  • the content of the present invention is not limited to the above embodiment.
  • the specific configuration of each step of the method for determining a failure in the analysis processing according to the present invention can be freely changed in various ways.
  • the specific configuration of each part of the analyzer according to the present invention can be variously changed in design.
  • the acceleration of the change in current not only the acceleration at one time but also the acceleration at a plurality of times is obtained, and even if one of these accelerations is a predetermined threshold value, If any of the following are present, it may be determined that a failure has occurred. Further, in the present invention, it is also appropriate to use the acceleration at which time point as the acceleration of the current change used for the failure judgment. This is a matter that can be selected.
  • the acceleration value of the current change or the threshold value may be appropriately corrected, and a fail judgment may be made based on the value after the correction. It depends not only to some extent but also to the conditions of each electrode and the reagent layer, and the acceleration of the change in current may fall below a predetermined threshold due to these conditions. On the other hand, according to the file determination method of the present invention, it is possible to appropriately detect such deficiencies.
  • the file judging method of the present invention it is not only possible to judge whether or not the amount of the sample introduced into the reagent layer is sufficient, but it is necessary to perform the analysis process. It is possible to widely determine whether or not a predetermined condition is satisfied.
  • the electrical physical quantity of the sample to be measured is not limited to the current, but may be another voltage or a change in charge.
  • a substance that reacts with cholesterol, lactic acid, or the like may be used instead of darcose in blood, and the concentration of these may be measured.
  • the reagent layer may not be used in some cases. Therefore, as the receiving member for receiving the sample, a member having no reagent layer can be used instead of the biosensor described above. Further, the receiving member itself may have a configuration in which a terminal for measuring a current or the like is not provided.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Electrochemistry (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)

Abstract

Un analyseur (A) comprend un moyen de mesure du courant (42) permettant de mesurer une grandeur physique électrique d'un échantillon et un moyen de mesure d'accélération (43) conçu pour mesurer l'accélération d'une variation de grandeur physique électrique telle qu'un courant mesuré par le moyen de mesure (42). Une évaluation de défaillance permettant de vérifier qu'une condition préétablie nécessaire pour permettre l'analyse de l'échantillon est effectuée sur la base de l'accélération mesurée par le moyen de mesure d'accélération (43). Il est ainsi possible d'effectuer précisément une évaluation de défaillance relative à l'analyse d'un échantillon.
PCT/JP2002/012035 2001-11-20 2002-11-18 Procede d'evaluation de defaillance aux fins d'une analyse et analyseur associe WO2003044514A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
JP2003546096A JP4260017B2 (ja) 2001-11-20 2002-11-18 分析処理におけるフェイル判断方法および分析装置
EP02781813.7A EP1452854B1 (fr) 2001-11-20 2002-11-18 Procede d'evaluation de defaillance aux fins d'une analyse et analyseur associe
US10/496,209 US7083712B2 (en) 2001-11-20 2002-11-18 Fail judging method for analysis and analyzer
AU2002349662A AU2002349662A1 (en) 2001-11-20 2002-11-18 Fail judging method for analysis and analyzer

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2001355324 2001-11-20
JP2001-355324 2001-11-20

Publications (1)

Publication Number Publication Date
WO2003044514A1 true WO2003044514A1 (fr) 2003-05-30

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PCT/JP2002/012035 WO2003044514A1 (fr) 2001-11-20 2002-11-18 Procede d'evaluation de defaillance aux fins d'une analyse et analyseur associe

Country Status (6)

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US (1) US7083712B2 (fr)
EP (1) EP1452854B1 (fr)
JP (1) JP4260017B2 (fr)
CN (1) CN1271406C (fr)
AU (1) AU2002349662A1 (fr)
WO (1) WO2003044514A1 (fr)

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JP2008304250A (ja) * 2007-06-06 2008-12-18 Gunze Ltd バイオセンサが接続される計測表示器および計測表示方法
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JP4260017B2 (ja) 2009-04-30
EP1452854A1 (fr) 2004-09-01
CN1271406C (zh) 2006-08-23
CN1589401A (zh) 2005-03-02
EP1452854A4 (fr) 2010-02-17
US7083712B2 (en) 2006-08-01
US20050000829A1 (en) 2005-01-06
EP1452854B1 (fr) 2015-02-25
AU2002349662A1 (en) 2003-06-10
JPWO2003044514A1 (ja) 2005-04-07

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